by April Breyer Menon | May 17, 2016 | Featured, News
In companion cases Acorda Therapeutics Inc. v. Mylan Pharm, Inc. (No. 2015-1456) and AstraZeneca AB v. Mylan Pharm. Inc. (No. 2015-1460), the Federal Circuit held that the District of Delaware may exercise specific jurisdiction over generic pharmaceutical company...
by April Breyer Menon | Jul 21, 2015 | Featured, News
On July 21, 2015, the Federal Circuit issued an opinion addressing two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that 42 U.S.C. § 262(l)(2)(A) does not require a biosimilar...
by April Breyer Menon | Jun 12, 2015 | Featured, News
On June 12, 2015, the Federal Circuit issued an opinion holding that claims directed to a method of detecting paternally inherited cell-free fetal DNA (“cffDNA”) in maternal plasma or serum are not patent eligible subject matter under 35 U.S.C. § 101. Ariosa...
by April Breyer Menon | May 14, 2015 | Featured, News
On May 13, 2015, a divided Federal Circuit panel, on remand from the United States Supreme Court, affirmed a district court finding of no direct infringement under 35 U.S.C. § 271(a), because a defendant did not perform all steps of the asserted method claims, and the...
by April Breyer Menon | May 12, 2015 | Featured, News
On May 5, 2015, the Federal Circuit issued an Order preventing Sandoz from launching its biosimilar drug, Zarxio® in the United States, pending a decision on Amgen’s motion for a preliminary injunction. Despite being FDA approved on March 6, 2015, Zarxio® will now not...
by April Breyer Menon | Mar 6, 2015 | Featured, News
March 6, 2015 was a turning point for the emerging U.S. biosimilars market. The U.S. Food and Drug Administration (FDA) approved Sandoz’s application to market Zarxio®, the first biosimilar drug in the U.S. Zarxio® (approved as “filgrastim-sndz”) is a biosimilar of...